NCHR Comments on FDA’s Proposed Rule “Medication Guides: Patient Medication Information”

November 29th 2023:

We appreciate the opportunity to comment on FDA’s proposed rule regarding: “Medication Guides: Patient Medication Information.”

The National Center for Health Research (NCHR) is a nonprofit think tank that conducts, analyzes, and scrutinizes research on a range of health issues, with a particular focus on which prevention strategies and treatments are most effective for which patients and consumers. We do not accept funding from companies that make products that are the subject of our work, so we have no conflicts of interest.

NCHR strongly supports the proposed rule to create standardized, easy-to-read, medication guides for prescription medications and biologic products. Replacing the two existing types of FDA-approved written drug information with a one-page patient medical information (PMI) guide that is simple and contains relevant drug information will help make medical information more accessible to patients and improve patient education.

We agree that the proposed PMI would provide essential information regarding the prescription drug that the patient is receiving by outlining drug name, indications, directions for use, safety information, and adverse side effects. Side effects should be quantified whenever possible, and if some types of patients are at higher risk, that should be specified.  In addition, we urge the FDA to include information regarding the benefit of the drug and the associated absolute risk reduction of their drug product in the PMI.  We are specifying that this should not be in terms of relative risk reduction, which is often misunderstood; for example, if the risk of a heart attack is 8% for patients not taking the drug and that is reduced to 6% for those taking the drug, that is a 25% relative risk reduction, but the absolute risk reduction for a patient considering the drug is only 2%. This information is likely to help patients have a more informed discussions with their physician about their treatment.

Other useful information to include in the PMI is a short list of drugs that either are known to interact poorly with the drug product, have a cytochrome P450 effect and either induce or reduce the efficacy of the drug product, or are contraindicated when taking the drug product. Including this information would help ensure an additional layer of patient safety and prevent the adverse risks associated with polypharmacy.

NCHR also suggests that the FDA implement more explicit plain language guidelines for the proposed PMI. The proposed rule states PMI submissions be “clear, concise, accessible,” and presented in a consistent, easily comprehensible format to aid patients in safely and effectively using their prescription drug products. While this description encapsulates the essence and purpose of plain language writing, it lacks specific guidelines to ensure that the PMI will meet these goals. Unfortunately, medication information packets have historically been written at reading levels that do not match the average level of the intended audience. The average reading level for adults in the U.S. is 7th-8th grade, and that means many adults are reading at an even lower level. Therefore, we recommend the FDA incorporates a set of guidelines and standards to ensure their plain language objectives are met. Providing clearer guidelines regarding PMI language and style requirements will result in better prepared applications and more beneficial materials for patients.

In summary, we support the FDA’s proposal on PMI guides and agree that plain language health information increases health literacy, enhances patient comprehension, and minimizes the risk of misinterpreting prescription drug information. However, we recommend that the FDA: 1) include information regarding the absolute benefits or risk reduction of the drug; 2) include information regarding problematic drug interactions, drug inducers or reducers, and medications that are contraindicated when taking the drug product; and 3) establish specific guidelines to meet the FDA’s objective of delivering PMI that is clear, concise, and accessible to patients, taking into consideration that approximately half the adults in the U.S. read at or below the 7th grade reading level.